Dáil Éireann Debate, Wednesday - 24 November 2021
162. Deputy Colm Burke asked the Minister for Health if the Government has considered the key issues identified in an assessment by a company (details supplied) of the reimbursement of medicines for rare diseases process which hinder access to rare disease medicines; and if he will make a statement on the matter. [57864/21]
Amharc ar fhreagra163. Deputy Colm Burke asked the Minister for Health if the Government will consider the reimbursement of orphan medicinal products to feature as part of the work programme of his Department for 2022; if he will consider Rare Disease Day 2022, which is the week starting 28 February, as an optimal time for a discussion and renewed focus on the topic; and if he will make a statement on the matter. [57865/21]
Amharc ar fhreagraI propose to take Questions Nos. 162 and 163 together.
I wish to advise the Deputy that my Department has not received the report to which the question refers and therefore cannot comment on the specifics of the assessment completed.
The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.
In line with the 2013 Health Act and the national framework agreed with industry, a company must submit an application to the HSE to have a new medicine added to the reimbursement list.
HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics (NCPE). Details of all NCPE rapid reviews and Health Technology Assessments (HTAs) are available on their website.
While the 2013 Health Act does not include provision for a different rule set when assessing orphan drugs, there are no legal barriers to the consideration of orphan drugs for reimbursement. In carrying out pricing/reimbursement assessments of new drugs, the HSE is mindful to take into account the unique circumstances that apply to orphan drugs, such as the small patient numbers and the nature of the condition to be treated.
The allocation of €50m for new medicines in 2021, described by the pharmaceutical industry as “a game-changer”, has had a significant impact on the availability of orphan drugs in Ireland this year. This funding has enabled the HSE to approve 43 new medicines/expanded uses of existing medicines to date (as of 12th November), 15 of which have been for the treatment of rare diseases.
The allocation of €30m for new medicines in 2022 will ensure that patients continue to get access to new and innovative medicines, including those for the treatment of rare diseases.
As outlined in the IPHA agreement, and in line with the 2013 Act, the HSE will decide, within 180 days of receiving an application (or a longer period if further information is sought from the company), to either add the medicine to the reimbursement list or agree to reimburse it as a hospital medicine, or refuse to reimburse the medicine.
The HSE strives to reach reimbursement decisions on all medicines, including orphan drugs, in as timely a manner as possible. However, it must ensure that the best possible price is achieved, as these commitments often represent multimillion-euro investments on an ongoing basis. This can lead to a protracted deliberation process.
There has been a number of key changes in the HSE assessment process of medicines within the confines of the 2013 Health Act. These have included changes to the HSE Drugs Group, whose membership has been expanded to include representatives from the National Patients Forum and more clinical expertise in the area of rare diseases.
In June 2018, the HSE Leadership appointed a Technology Review Committee for Rare Diseases (RDTRC) to complement the existing assessment process. This Committee’s reviews provide an opportunity for input from patients and families impacted by rare diseases, as well as from clinicians with expertise in the treatment of rare diseases.
Any potential new work streams for 2022 in relation to new medicines (for the treatment of rare diseases or otherwise) will be considered in the context of the HSE’s upcoming National Service Plan.
